Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

NCT ID: NCT00646958

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-04-30

Brief Summary

The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections

Conditions

Infectious Skin Diseases; Bacterial Skin Diseases; Staphylococcal Skin Infections; Streptococcal Infections; Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Radezolid 450 mg PO QD

Group Type: EXPERIMENTAL

Radezolid

Intervention Type: DRUG

450mg PO QD

2

Radezolid 450 mg PO BID

Group Type: EXPERIMENTAL

Radezolid

Intervention Type: DRUG

450mg PO BID

3

Linezolid 600 mg PO BID

Group Type: ACTIVE_COMPARATOR

Linezolid

Intervention Type: DRUG

600mg PO BID

Interventions

Radezolid

450mg PO QD

Intervention Type: DRUG

Radezolid

450mg PO BID

Intervention Type: DRUG

Linezolid

600mg PO BID

Intervention Type: DRUG

Other Intervention Names

RX-1741; RX-1741; Zyvox

Eligibility Criteria

Inclusion Criteria

• Adult patients with uSSSI
• Adult (men and women) ≥18 years
• Females must be post-menopausal for at least 1 year or surgically sterile
• Sexually active males must use a barrier method of birth control during and for 30 days after the study
• Acceptable clinical diagnoses of uSSSI include, but are not limited to: Simple abscess, Impetiginous lesions, Folliculitis, Furunculosis, Carbuncles, Cellulitis
• The infection is accompanied by 2 or more of the following local signs and symptoms: Pain/tenderness, Swelling, Erythema, Localized warmth, Purulent drainage/discharge, Induration, Regional lymph node swelling or tenderness, Extension of redness
• A sample for microbiologic culture must be obtained from the primary infection site at the screening visit
• The patient must require and be a suitable candidate for oral antibiotic therapy in the opinion of the Investigator and be able to swallow tablets or capsules intact
• A written, voluntarily signed informed consent must be obtained from the patient prior to the initiation of any study-related procedures

Exclusion Criteria

• Cellulitis (area greater than 10cm2), chronic or recurrent furunculosis, postoperative wound infection, leg ulcer, decubitus ulcer(s), erysipelas, progressive lymphangitis, acute paronychia or a deep tissue abscess such as pilonidal or breast abscess. Also excluded are skin infections resulting from animal bites
• Patients with a complicated skin and skin structure infection as judged by the Investigator
• Infections that can be treated by surgical incision alone according to the judgment of the Investigator
• Treatment with the following anti-infective agents prior to study drug administration: systemic antibiotic within 7 days; azithromycin within 14 days; a long-acting injectable antibiotic within 30 days
• Any infection which requires the use of a concomitant antimicrobial agent, in addition to study drug
• Concomitant topical therapy at the infection site for the period within 48 hours prior to study drug administration through TOC
• A chronic or underlying skin condition at the site of infection or infections involving prosthetic materials
• A wound secondary to burn injury or acne vulgaris
• Any infection site that requires: intraoperative surgical debridement; excision of infected area
• Documented or suspected bacteremia
• Fungal infection involving the nail bed or scalp at the primary uSSSI site
• Significant peripheral vascular disease
• An abscess at an anatomical location where the incidence of anaerobic pathogen involvement is increased
• Patient receiving a daily dose of > 15 mg of systemic prednisone or equivalent, for > 10 days within the period starting 14 days prior to study drug administration or anticipated through TOC
• Patient with known human immunodeficiency virus (HIV) infection.
• Medical history of hypersensitivity or allergic reaction to linezolid according to the judgment of the Investigator
• Patients receiving serotonergic agents, selective serotonin reuptake inhibitors (SSRIs), or monoamine oxidase inhibitors (MAOIs)
• Patients who have severe liver disease
• History of pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled hypertension, carcinoid syndrome
• Evidence of uncontrolled, clinically significant (according to the judgment of the Investigator) cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine disease; malignancy or psychiatric disorder
• Current evidence of deep vein thrombosis or superficial thrombophlebitis
• Experienced a recent clinically significant coagulopathy
• Evidence of clinically significant immunosuppression
• Patient who previously enrolled in this study
• Patient who has previously enrolled in any other clinical trial within 4 weeks of enrollment through TOC. Treatment with an investigational drug within 4 weeks prior to study drug administration
• Patient residing in a chronic care facility
• Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluation of the absorption of study drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Hopkins, MD

Role: STUDY_DIRECTOR

Melinta Therapeutics, Inc.

Locations

Drug Research & Analysis Corp

Montgomery, Alabama, United States

OWENS Pharma Research Center

Long Beach, California, United States

Healthcare Partners Medical Group

Los Angeles, California, United States

HealthCare Partners Medical Group

Pasadena, California, United States

Olive View- UCLA Center, Dept. Emergency Medicine

Sylmar, California, United States

South Florida Clinical Research

Atlantis, Florida, United States

Southeast Regional Research Group

Columbus, Georgia, United States

Contemporary Medicine, LLC

Hinesville, Georgia, United States

Infectious Disease of Indiana, PSC.

Indianapolis, Indiana, United States

Clinical Trials of America, Inc.

Shreveport, Louisiana, United States

Arnold Markowitz, MD., PC

Keego Harbor, Michigan, United States

Mercury Street Medical Group, LLC

Butte, Montana, United States

Jamaica Hospital Medical Center

Jamaica, New York, United States

ALL-TRIALS Clinical Research, LLC

Winston-Salem, North Carolina, United States

Summa Health System

Akron, Ohio, United States

Brandywine Clinical Research

Downington, Pennsylvania, United States

Warminster Medical Associates, P.C.

Warminster, Pennsylvania, United States

McKenzie Medical Center

McKenzie, Tennessee, United States

J. Lewis Research, Inc.

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

RX-1741-202

Identifier Type: -

Identifier Source: org_study_id